Green Tea Study - Fact or Fiction

In 2005, a green tea company called Ito En Ltd. asked the FDA for permission to put a claim on their labels that said drinking 5 ounces of green tea daily might reduce the risk of cardiovascular disease (CVD). To back up their claim, they submitted 105 studies, articles and other publications. Nearly a year later the FDA said no, insisting that, "There is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with CVD."

Yet over the past 25 years, countless studies showing the positive effects of green tea on several important risk factors for cardiovascular disease have been published in scientific journals. So was the FDA wrong? Or was the green tea claim untrue? The answer is a resounding "neither." The fault lay on both sides. Here's why:

• The petitioner's claim was irresponsible. Ito En Ltd. wanted permission to say that drinking just 5 ounces of green tea daily could reduce several risk factors for cardiovascular disease. Yet most studies have shown that green tea reduces certain CVD risk factors with a daily intake of 4-5 cups, and improves cholesterol at about 10 daily cups. One-half cup (5 ounces) daily? That's a hard case to prove and not even a realistic test.

• The FDA used an antiquated definition of CVD risk factors. The case got even harder to prove when the FDA narrowed the definition of a cardiovascular disease risk factor to high total cholesterol, high LDL cholesterol or high blood pressure. That meant that all studies showing that green tea helps fight oxidized LDL, obesity, stress, low HDL, diabetes or platelet stickiness simply didn't count. Many studies were ignored.

The only studies the FDA deemed worthy of consideration were human studies - all animal and "test tube" studies were ignored. And not all kinds of human studies were included - review studies and meta analyses were considered background information only. The evidence was winnowed down. Because of all of these restrictions, the FDA managed to reduce the 105 submitted studies, articles and papers to a grand total of only 11! And it was on the basis of these 11 studies that the FDA concluded that there was "no credible evidence to support qualified health claims" for green tea and a reduction in CVD risk.

Was the FDA wrong? According to their current standards, no. However, the FDA desperately needs to acknowledge such well-documented and universally accepted CVD risk factors as increased LDL oxidation, excess body weight, low HDL, diabetes and increased platelet "stickiness" - all of which are positively influenced by green tea.

It would also help if future petitioners would consider recommending up to 10 cups of green tea per day (or the equivalent in green tea extract) instead of the ridiculously small amount of 5 ounces. And, last but not least, we need researchers to conduct more human studies on green tea's effects on CVD. Then maybe next time we'll have the ammunition we need to get the FDA's much-wanted stamp of approval.